Clinical Research Associate

hace 2 semanas

Madrid, Madrid, España Boston Scientific A tiempo completo
About this role:

The Clinical Research Associate (CRA) plays a critical role in supporting the Global Clinical Operations (GCO) Center of Excellence at Boston Scientific. As a key member of the team, you will be responsible for conducting clinical trial site start-up activities, ensuring compliance with regulatory requirements, and collaborating with divisional and regional clinical teams.

Key responsibilities:
  • Coordinate site regulatory submissions and essential document collection for allocated clinical research sites.
  • Manage multiple sets of essential regulatory documents across several studies and division portfolios.
  • Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF).
  • Develop and foster clinical research site relationships to become a subject matter expert in the site start-up regulatory process.
  • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
  • Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
  • Manage and problem-solve site start-up challenges that arise to mitigate impact to service level agreement and study goals.
  • Develop, prepare, complete, and track required regulatory, ICF, and legal documentation.
  • Document clinical research site and investigator readiness for participation across multiple studies.
  • Support internal quality audits, regulatory inspections, as applicable.
  • Update and maintain study-specific startup and close-out trackers.
  • Update and maintain site-specific metrics in Clinical Trial Management Systems, file, and maintain site documents in eTMFs.
  • Provide updates to leadership on site start-up activities, investigator readiness, regulatory submission, approval status, etc.
  • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinators, divisional clinical study leads, and/or other stakeholders when appropriate.
Requirements:
  • Bachelor's Degree, or an equivalent combination of experience and education.
  • Experience in study submissions to the Ethics Committee (Spain or Italy).
  • Fluency (written and spoken) in English, Italian, and Spanish.
  • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment.
  • Ability to work in a team environment and possess clear, concise communication and presentation skills – written and verbal.
  • Must be comfortable interacting with clinical research site personnel via phone, email, and in person.
Preferred qualifications:
  • Research Coordinator or In-House Clinical Research Associate/Clinical Research Associate/Study Start-up Specialist experience.
  • Experience working with Ethic Committee's.
  • Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems/eTMF.
About Boston Scientific:

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.

  • Senior Clinical Research Associate

    hace 1 semana

    Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo

    About UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to advance new medications from discovery to reality.Our MissionWe are committed to delivering high-quality clinical research programs that meet the needs of our sponsors and patients. Our team of over 3,000...

  • Senior Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo

    Job Title: Senior Clinical Research AssociateAbout Us:Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Our Mission:We are united in cause with our...

  • Senior Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Worldwide Clinical Trials A tiempo completo

    Job Title: Senior Clinical Research AssociateAbout Us:Worldwide Clinical Trials (Worldwide) is a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Our Mission:We are united in cause with our...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Clinical Research Associate OpportunityThermo Fisher Scientific is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Barcelona. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with cross-functional teams to ensure the delivery of high-quality...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Clinical Research Associate OpportunityThermo Fisher Scientific is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Barcelona. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with cross-functional teams to ensure the delivery of high-quality...

  • Clinical Research Associate

    hace 3 días

    Madrid, Madrid, España Worldwide Clinical Trials, Llc A tiempo completo

    Job SummaryWorldwide Clinical Trials, LLC is seeking a highly skilled Clinical Research Associate - Site Management to join our team. As a key member of our clinical operations team, you will play a vital role in ensuring the successful execution of our clinical research programs.About the RoleAs a Clinical Research Associate - Site Management, you will be...

  • Senior Clinical Research Associate

    hace 1 semana

    Madrid, Madrid, España Worldwide Clinical Trials, Llc A tiempo completo

    Job Title: Senior Clinical Research AssociateAt Worldwide Clinical Trials, we are seeking a highly skilled Senior Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of our clinical research programs.Key Responsibilities:Conduct site qualifications,...

  • Clinical Research Associate

    hace 4 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Unlock Your Potential as a Clinical Research AssociateAt Thermo Fisher Scientific, we're committed to empowering our customers to make a positive impact on a global scale. As a Clinical Research Associate, you'll play a vital role in bringing our mission to life by enabling the development of life-changing therapies.Our Clinical Operations team in Spain is...

  • Clinical Research Associate

    hace 4 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Unlock Your Potential as a Clinical Research AssociateAt Thermo Fisher Scientific, we're committed to empowering our customers to make a positive impact on a global scale. As a Clinical Research Associate, you'll play a vital role in bringing our mission to life by enabling the development of life-changing therapies.Our Clinical Operations team in Spain is...

  • Clinical Research Associate

    hace 1 semana

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Unlock Your Potential as a Clinical Research AssociateAt Thermo Fisher Scientific, we're committed to accelerating research and solving complex scientific challenges. As a Clinical Research Associate, you'll play a vital role in our mission to make the world healthier, cleaner, and safer.About the RoleWe're seeking a highly motivated and organized Clinical...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Mygwork A tiempo completo

    Unlock Your Potential in Clinical ResearchThermo Fisher Scientific is a leading global biotechnology company that enables our customers to make the world healthier, cleaner and safer. We are seeking a highly motivated and experienced Clinical Research Associate to join our team in Barcelona, Spain.About the RoleAs a Clinical Research Associate, you will be...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Mygwork A tiempo completo

    Unlock Your Potential in Clinical ResearchThermo Fisher Scientific is a leading global biotechnology company that enables our customers to make the world healthier, cleaner and safer. We are seeking a highly motivated and experienced Clinical Research Associate to join our team in Barcelona, Spain.About the RoleAs a Clinical Research Associate, you will be...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Unlock Your Potential as a Clinical Research AssociateAt Thermo Fisher Scientific, we're committed to empowering our customers to make a positive impact on a global scale. As a Clinical Research Associate, you'll play a vital role in bringing our mission to life by enabling the development of life-changing therapies.Our Clinical Operations team in Spain is...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Unlock Your Potential as a Clinical Research AssociateAt Thermo Fisher Scientific, we're committed to empowering our customers to make a positive impact on a global scale. As a Clinical Research Associate, you'll play a vital role in bringing our mission to life by enabling the development of life-changing therapies.Our Clinical Operations team in Spain is...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job Title: Clinical Research AssociatePrecision Medicine Group is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a key role in the development and execution of clinical trials, ensuring that all aspects of the study are conducted in accordance with regulatory requirements and company...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Precision Medicine Group A tiempo completo

    Job Title: Clinical Research AssociatePrecision Medicine Group is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a key role in the development and execution of clinical trials, ensuring that all aspects of the study are conducted in accordance with regulatory requirements and company...

  • Clinical Research Associate

    hace 1 semana

    Madrid, Madrid, España Thermofisher Scientific A tiempo completo

    Job Title: Clinical Research AssociateAt Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Research Associate, you will play a critical role in supporting our customers in the development of life-changing therapies.Key Responsibilities:Conduct monitoring activities...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Clinical Research Associate RoleAt Thermo Fisher Scientific, we're committed to making a positive impact on a global scale. As a Clinical Research Associate, you'll play a crucial role in bringing our mission to life by enabling our customers to make the world healthier, cleaner, and safer.We provide our teams with the resources needed to achieve individual...

  • Clinical Research Associate

    hace 2 semanas

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Clinical Research Associate RoleAt Thermo Fisher Scientific, we're committed to making a positive impact on a global scale. As a Clinical Research Associate, you'll play a crucial role in bringing our mission to life by enabling our customers to make the world healthier, cleaner, and safer.We provide our teams with the resources needed to achieve individual...

  • Clinical Research Associate

    hace 3 días

    Madrid, Madrid, España Thermo Fisher Scientific A tiempo completo

    Role SummaryThermo Fisher Scientific is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Barcelona. As a Clinical Research Associate, you will be responsible for managing clinical trials from start to finish, ensuring compliance with regulatory requirements and company policies.Key ResponsibilitiesManage clinical...